APPCO FDA Approval ANDA 206762

ANDA 206762

APPCO

FDA Drug Application

Application #206762

Application Sponsors

ANDA 206762APPCO

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL50MG0VORICONAZOLEVORICONAZOLE
002TABLET;ORAL200MG0VORICONAZOLEVORICONAZOLE

FDA Submissions

UNKNOWN; ORIG1AP2016-05-24STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

RISING
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206762
            [companyName] => RISING
            [docInserts] => ["",""]
            [products] => [{"drugName":"VORICONAZOLE","activeIngredients":"VORICONAZOLE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VORICONAZOLE","activeIngredients":"VORICONAZOLE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/24\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-05-24
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.